Medical Affairs Focus

Thoughts on the challenges of leading global Medical Affairs

Topic 30: Virtual MA Organizations – Leadership Implications

I have posted about outsourcing in MA in past posts here and here.

Today’s topic is focused on the virtual MA organization – an organization that outsources all or almost all of its key functions.  Given the capabilities of service providers, it is entirely feasible to outsource every sub-function within MA, including medical communications, grants management, medical information, standard and specialty field forces / MSL groups.

My goal today is not to discuss the pros and cons of a decision to form a virtual MA organization but instead to discuss some key aspects to making a virtual MA organization successful.  Although today’s post is looking at a fully virtual MA, the key points would be just as relevant for a mixed virtual and internal MA organization.

Reality of Virtual MA Organizations

Most organizations that decide to use virtual MA are organizations where very little MA infrastructure exists.  Either they are small organizations building their first MA function or they are mid-sized organizations that are going into a new TA.  Regardless of situation, the analysis that leads to a virtual MA organization is usually a buy vs. build decision.  When considering how to make virtual MA successful, we need to start at that point.

Keys to Success

There are three keys to success to managing a virtual MA organization:

  • Upfront Expectations
  • Sufficient Internal Management Resources
  • Structured System for Evaluations

Upfront Expectations
In order for the virtual MA organization to be successful, the vendors that provide the services need to have a clear understanding of what is expected of them and when so that they can develop the correct scope of the work for their pricing.  Defining what is expected of the vendor is easier in some cases, like for Medical Information defining expectations about call wait time and speed of fulfillment.  But, defining expectations is much harder in cases like an MSL group or a specialty education group.  This challenge is heightened by the fact that the reason some organization’s decided to go virtual is that they don’t have a lot of expertise in house.

Nevertheless, it is vital that a clear set of expectations and measures are agreed upon as a part of the vendor selection and contracting process.  There is no point in the process where the company has more control than at the point of contracting.  If clear expectations are set, both sides win because the vendor can appropriately staff and manage the group and the company can achieve their goals.  If not, the vendor may either need to increase the scope during the contract or simply fail to achieve some needed result and the company will face unexpected costs and missed expectations.

In order to set the right expectations a strategy for MA’s work for the next period must be developed in detail.  And this strategy should be developed before the vendor selection process occurs to ensure that the vendors are supporting the strategy not the strategy supporting the vendors.

WARNING: Some vendors in our industry will encourage buyers against doing this work in advance.  The vendors will tell the buyers that the vendor will develop these expectations after the contract is signed and/or after they are active.  Companies that take this approach usually end up spending much more than they expected and achieving less results than they expected.

Sufficient Internal Management Resources

Virtual does not mean management free.  While the vendors will definitely have their own managers, successful virtual MA organizations have learned that they need to closely manage the vendors to achieve expected results.

Given the situation that leads to a virtual MA organization as discussed above, it sometimes comes as a shock to those setting up one that they still need to hire.  And those hires need to be managerial-level staff.

A general rule of thumb is the greater the range of responsibilities and lack of clarity, the greater the need for management.  So, for example, outsourcing a MedInfo group, with clear metrics and expected volumes, might require only a ¼ Associate Director.  But managing an outsourced MSL group during launch, even if there is a clear expectations set up-front, would require a ½ time director to deal with the unexpected and new learnings from the healthcare community.

If the company is unwilling to invest in the resources needed to manage the virtual MA vendors, that is a sign that the value of MA is not really understood within the organization.  Unless that core issue is addressed it is unlikely that the virtual MA group will be successful.

Structured System for Evaluations

In addition to being actively managed, virtual MA vendors need to be on a half yearly or yearly structured evaluation process.  The structured process will force a review of the original goals and scope of the relationship and provide an opportunity to resolve ongoing issues.  Without a structured process for reviews, problems tend to fester and eventually result in a complete breakdown of the relationship.

Many companies entering into a virtual MA environment rely on the vendors to suggest the structures of these types of meeting.  I would recommend that the company own the process and set the agenda.  This will ensure that those issues most important to the company serve as the focus of the process as opposed to an add on.  It also avoids the “make the case for added scope” that many vendor-driven processes tend to become.

Do you have experience setting up or managing a wholly or partially virtual MA organization?  What would you recommend?  Please leave a comment or send me a message.

Topic 29: “An American in Paris” – Inheriting an EU-based Field Force

A reader (and now friend) recently contacted me with an interesting challenge and agreed to allow me to recap our discussions here (de-identified, of course).

He/she was recently promoted into global responsibilities for managing the MA field force.  For their mid-sized biopharma company, global meant US and EU and this person already had managed the US field force.  He/she wanted to discuss keys to taking on the EU MSLs (although they use a different term).

1.    Time to make your “Grand Rounds” of the EU

Although no one has the time or budget, it is critical to find a way to meet with the EU MSL team members in their individual countries, rather than as a set.  Given the way many EU country organizations are run, the MSL may be significantly more focused on their country-level needs than overall EU level needs.  So you need to go out to the countries and meet them and their key internal stakeholders in the country leadership.  MA’s work with commercial can be more flexible in the EU than in the US, so it is important to explore how the MSLs are supporting their country needs.

This is a critical time to listen and not judge.  The goals and programs of the MSLs tasks can differ quite a bit from the mean country to country.  It is not unusual to find some activities that strike you as being in the grey area (by EU standards) have crept into the MSL remit, especially if the country lead is unclear on the standards and the MSLs don’t hold to the standards clearly.   These activities are usually driven by some high-value, country-specific scientific need so you need to be careful about simply pulling the plug.  Instead you should first explore the compliance aspects (see next point below) and if you decide to terminate them, work with the local stakeholders to find a more compliant alternative.

Regardless, you should come away from the Grand Rounds understanding not just your new MSL team but the environment in which they operate.

2.    Make friends with EU Compliance internal resource or get name for who the organization uses externally to support compliance in the EU

My friend understood that the difference between the EU regulatory environment and the US environment in general, but one of the key points when first managing MSLs in the EU as an American is to break the US-conditioned mind-set that EU countries are the equivalent of US states.  While everyone understands this, it is very common to fall into assumptions about a broad set of rules that apply equally to all of the EU.  There are some of these (privacy laws being one of the biggest differences from the US) but there are also a range of country-specific rules which must be taken into account when considering MSL goals and activity in the EU.

If you are lucky enough to have in-house compliance counsel with EU expertise, my recommendation is that you approach them after each of your country visits, which will allow them to tackle the issues without overloading them.  If you use outside counsel, hold all your questions until the end since them always seem more efficient when you give them a raft of questions vs. one or two at a time.

3.    Determine how much global alignment you want to force

Determining how similarly you want to run the US and EU groups should be carefully considered.  It is possible to force full alignment between the US and the EU, one set of rules, standards and measures for all.  The downside is that you have to go with the strictest regimen between the US and the EU and countries, and this can really stand in the way of effectiveness on both sides of the Atlantic.

Instead, I suggest maintaining two sets of standards.  For example, given the different compliance regimes, to maximize the value in each country a different set of SOPs may be reasonable, despite the cost and inefficiency of having two sets.  Systems may need to vary given EU privacy rules or at least communication about the content of the system.  Even basic metrics and measures of performance will likely need to vary.

What advice do you have for the “American in Paris”?  Leave a comment.

And if you are new to the blog, don’t forget to enter your email and get new blog posts sent directly to your in-box.

QuickNote: Sunshine Act – Are Mechanics Crowding Out Relationship Management?

Readers of this blog know that I have strong opinions about MA’s role in the success of the Sunshine Act in their companies.  MA is responsible for long-term scientific engagement with the company’s top external experts, and these are the very people most likely to be negatively impacted by the Sunshine Act compliance if it is handled wrong.  Clinical is focused on the next study, commercial is focused on the next sale, only MA is focused on the overall relationship.

It is for that reason that I have been increasingly concerned when a number of my friends in the industry have told me how little, if at all, many MA organizations have been engaged in the efforts so far.  To be fair, many organizations are focusing on the mechanics right now – gathering the right data, centralizing data from a range of different sources, coding it in the right way and reporting it effectively – most if which is not the responsibility of MA.  Nevertheless, precious time is being wasted on the relationship side of this effort.

So, this is my call to action.  If by June 1, your organization has not begun an overall communications and relationship management plan spearheaded by MA, you are officially behind the curve.  The data will need to be collected as of August 1, and your MSLs should be explaining the why’s and what’s of this process before that data begins to be collected.  They can’t do that without a thorough communication plan.  And, some KOLs are likely to react in a less than positive way to this development – you need a plan to handle this as well.

The platform is burning – time to push ahead and take the lead in this effort!

Topic 28: Big Data and Medical Affairs

“The era of Big Data is here!”  That may be true but what does that mean for Medical Affairs?  As in all of biopharma, MA is comfortable working with data.  So much of our work revolves around discussing data and the implications of data that many people may think that we were already living in the era of Big Data.

But for most MA organizations, the data sets we have focused on are purpose generated – either our own data or data from similarly-scaled studies conducted by others.  Big Data refers to something different.  I like the differentiation that SAS uses when comparing Big Data to the past data sets.  They break it down to four “V”s and a C:

  • Volume: Hugely increased data volume from the past
  • Variety: Since the data is produced in many different ways, it has many different formats and structures
  • Velocity: Both how fast the data is being produced and how fast it must be processed
  • Variability: Inconsistent data flows, with peaks and valleys
  • Complexity: Driving value out of these data sets is highly complex and difficult

This is not your grandfather’s data sets.  What are some examples of Big Data as relevant to biopharma and MA:

  • Electronic Health Records data from a variety of sources
  • Search engine data (see an example of analyzing search data to find safety signals here)
  • Sunshine Act Physician Spend Data (when it becomes available)
  • Social media data
  • Competitors clinical trial data as it is released

Contained within these and many Big Data sources are key tools for MA:

  • Valuable therapeutic information
  • Unique customer insights
  • KOL identification and information
  • Visibility of competitors drug development and support efforts
  • Important drug safety signals

But, none of these benefits can be achieved unless the question is asked and the data is analyzed.  I would suggest that effective MA organizations of the future will need to have the capacity to ask and answer these types of questions.

In order to do so, MA organizations will either need to build or have access to increased levels of biostatistical and epidemiological resources.  And these resources need to have skills directly related to Big Data.  The characteristics that differentiate Big Data from existing data sets also means that many existing biostats and epi staff do not have the expertise or confidence working with these large, external data sets.  MA organizations need to ensure that people with exactly these skills sets are available within their organizations or from outside vendors and that these resources have the capacity to support MA.

Then, MA needs to improve its overall level of confidence defining Big Data questions, conducting Big Data analysis, and discussing the results with others.  Given the difference in the source of this type of data, the way this data is presented and discussed must be different too.  Everyone in MA, but especially the MSLs, must become more comfortable understanding the nuance of this type of data analysis and discussing both the strengths and weaknesses of working with Big Data.

The era of Big Data is here.  MA has a long history of effectively using data and explaining data in support of its organization.  MA leaders must investigate and embrace Big Data to take advantage of all the tools available today.  The questions unasked are always the questions unanswered.

What is your experience with Big Data?  Please leave a comment.

Topic 27: Disruptive Change in CD and the Opportunity it Presents to MSLs

Disruptive change is a frequent topic on this blog because it represents both a threat and opportunity for MA Leaders.  For example, I have discussed the Caronia ruling at length because it could fundamentally alter the relationship between MA and Commercial.

Clinical Development is facing a disruptive change of its own that not only will alter the way it works but offers an interesting opportunity for some MSL groups.

As most of my readers know, one of the largest expenses in executing a clinical trial is monitoring costs.  The need to send a human being to each site every 4 to 8 weeks during a trial to manually review the paper source records and compare those results to the data entered in the electronic data capture (EDC) system accounts for roughly 30% of a major study’s budget.

However, this is about to change.  With the rise of tablet computers and ubiquitous internet, a range of technology platforms are now available to allow for the elimination of paper-based source records.  For example, the company Clinical Ink, provides a Windows tablet that completely eliminates the need for paper source records by recording not just that data required for the study sponsor (which is what is in the EDC) but also the data needed by the physician administering the study to manage their records.  Once the physicians can eliminate the need to keep separate paper records, the last stumbling block to all electronic source records will have been overcome.

All electronic source records is a highly disruptive change to clinical development.  All electronic source records means that source data verification no longer needs to occur on-site.  The majority of the monitoring visits could be eliminated and the role of the Clinical Research Associate (CRA)  versus role of the Clinical Data Manager (CDM) will change significantly.

Today CRA’s do more than just monitoring visits.  They also conduct site initiation visits, and other high-visibility meetings with the site to ensure that it is on track. However, when you eliminate the need for monitoring visits, it opens an opportunity to ask if the CRA is really the best representative to provide other support to the site.

I would suggest that this disruptive change offers and opportunity for the MSLs to step up and serve as the face of the company for key studies.

Already many MSL groups get involved in this manner along side CRAs for key studies.  In the future MSLs could replace the CRAs for the customer-facing aspects of key studies, just like CDMs will replace CRAs for the electronic source data verification processes.  It would require changes to SOPs and some additional work and training for the MSLs but the benefits for the organization would be significant:

  • MSLs already have relationships with many KOLs which serve as PIs and this is an opportunity to strengthen that relationship as well as build new relationships
  • MSLs work for the company and therefore understand the importance of building and maintaining long-term positive relationships with the PIs (as opposed to CRAs which are often outsourced and only focused on a single study)
  • MSLs have superior scientific training than most CRAs and thus can make a stronger case for the scientific importance and structure of the study, which is cited by PIs as one of the key factor’s driving their willingness to engage in the study
  • MSLs can have peer-to-peer discussions with the PIs to ensure that they understand the protocol
  • MSLs often glean key scientific insights from PIs when working with them on studies that can be brought back and shared with the organization’s scientific leadership
  • MSLs can offer their scientific opinion on aspects of the trial that may be limiting recruitment given their in-depth engagement

These are just a few of the benefits for engaging the MSLs in this new manner.  But, like all disruptive change, this is not going to come about naturally.  For MSLs to engage in this new manner, MA Leadership will need to reach out to their CD counterparts, discuss this disruptive change and push for a new role for MSLs.

What are your thoughts?  Leave a comment or send me an email.

Welcome to MA Focus Blog

Welcome!   I have been getting some new readers and I wanted to welcome you to the MA Focus blog.  My goal with the blog is to discuss issues that are relevant to MA leaders.  I encourage you to add your email to the distribution list (use the “Follow this blog”  link on the right) so you will be notified when there is a new post.  Promise, no spam!

Please take the time to look over some of our archives.  We have discussed a range of topics including MSL proactivityKOL identification, MedComm/SciComm groupsMA at Product LaunchGlobal MA and MA’s Relationship with Commercial, just to name a few.

Finally, I really enjoy feedback so please feel free to leave comments or email directly with questions (link on right).

Thanks for your interest.

Topic 26: Highlights of Day 3 of the Medical and Scientific Communications 2013 Forum

­

The final half day for the MSC meeting had an excellent and well received discussion about MSL metrics.  I also attended an interesting talk on coordinating global publications.  My take on it below

DISCLAIMER:  My focus is on interesting information, I did not try to take verbatim notes and will not try to assign comments to a particular speaker.  Any mistakes are mine alone.

In no particular order, some of things are found interesting included:

-  Metrics

  • Must vary as focus of the organizations varies
    • Plays back to earlier comments about staying focused if you want to see improvement over time
    • Mix of Activity, Value and Compliance measures are needed
    • IIS Metrics
      • Good to track in terms of just a sense of the program
      • NO goals should be put in place
      • Additional metrics discussed
        • Engagement with ACOs or Cancer Networks or other new healthcare entities
        • Congress attendance valued by quality metric of the outputs not the activity
        • Dollars saved by asking MA to assist CD, especially when CD has a bid from a vendor to provide the same service
        • Internal stakeholder feedback
          • Important – best to solicit directly via email/conversation
          • BE CAREFUL – some organizations do not allow feedback from Commercial

-  Reports/Dashboards/Scorecards

  • Need to develop different outputs for different stakeholders
  • What is needed internally at MA is not what you want to focus on with other internal stakeholders
  • Always pair summarized numbers with text explaining value and highlighting accomplishments/learnings

-  MA IT Systems

  • As mentioned earlier, a number of companies seem to be moving toward the Veeva Platform which is built on top of Salesforce.com CRM.
    • Veeva seems to be driven by the commercial side, but it has MA capabilities
    • Some people mentioned that you need to be careful about Veeva training and documentation as it often defaults to commercial language
    • Some organizations use it to track not only KOL interactions but also time spent in the office doing various projects
    • Focus on time tracking seemed to be for internal management not for external publication

-  Global Publication Coordination

  • Increasingly important to have global plan
  • Much easier to manage when Pub Team gets involved earlier in the development cycle
  • MA on Pub Team should work as a facilitator for Pub Team’s interaction with other functions given their central role
  • Press release management globally remains a major challenge
    • General consensus that prior to first presentation at a meeting, press release should be simply binary – met endpoints, did not meet
    • Too much data in press release can tick off journals threatening publication

-  Odds and Ends Ideas

  • Heard from a number of different companies that MSL groups focused on payer support in the US need to be between 6 and 10 in size to cover all the needs – not scientific but an interesting convergence
  • MSLs at clinical study initiation visits:
    • Good idea BUT has GCP implications
    • Need to hammer out how MSLs can fit within CD’s SOPs with ClinOps before engaging
    • May ultimately require update to CD’s SOPs

Obviously, this is merely a few key concepts from the day but it should give you some flavor of the type of discussions and the focus of the meeting.

If you were at the meeting and have other thoughts please leave them in the comments.

Topic 25: Highlights of Day 2 of the Medical and Scientific Communications 2013 Forum

A great second day for the MSC meeting, with a range of interesting topics.  My take below.

DISCLAIMER:  My focus is on interesting information, I did not try to take verbatim notes and will not try to assign comments to a particular speaker.  Any mistakes are mine alone.

In no particular order, some of things are found interesting included:

-  MSL Value Proposition:

  • Questions of value are often linked with a lack of fully understanding what a modern MSL does, vs. MSLs of old
  • Many in group have had good success inviting key stakeholders, up to and including CEO, for ride-alongs with MSL
    • Proven track record at overcoming skeptics about MSL skills and value
    • One key to proving value is remain consistent in priorities to show value over time
      • When priorities are shifting its hard to build up track record
      • Remember that one of the greatest MSL values, relationships, is the least structured and always make that point clear

-  Other non-traditional areas where MSLs can show value:

  • Training CRAs on underlying science before trials
  • Conducting formal evaluations of CME vendors to ensure vendors are providing good value
  • Identifying authors for Pub group

-   Measure what matters to the people that matter

  • Develop measures that highlight accomplishments that only MSLs can achieve
  • Create monthly list of these unique accomplishments to address qualitative questions

-  External Surveys

  • Important to get qualitative measures
  • But expensive and difficult
  • Also, expect lots of push back from people who don’t think they are fair
  • Don’t let the complainers win, the data is critical to effectively target efforts

-  A number of MSL organizations use monthly internal newsletters

  • Highlight key activities and accomplishments
  • Provide some science training
  • Implicitly defines values and culture through examples chosen and emphasis

-  Challenge of “boom bust” in MSL team sizing

  • Number of speakers referred to the challenge of staffing for launch only to see the team significantly reduced 1 to 2 years after launch
  • This is especially challenging outside of the US where country-level resources are very limited
  • Need to consider this issue up-front during initial staffing and make the case for the long term from the start

-  Breakout session about MSL management

  • Almost everyone in group had turnover of less than 10% and most less than 5%
  • Most organizations had two non-managerial  levels of MSL – MSL and Sr. MSL
    • Some organizations had three with an Executive MSL above Sr.
    • Most organizations had at least two managerial levels but the titles varies
      • Some had three
      • Expectations about activity level varied but some examples from different companies:
        • 4 visits per week
        • X number of interactions per week (phone/email/visit)
        • MSLs will be out in the field 3 to 4 days per week
        • Key to expectations is flexibility
          • Some MSLs in small geogs some in large, their expectations should be different
          • Some TAs have large number of meetings, some few, so their expectations should be different

-  Mobile technology

  • IPADS is the de-facto mobile tech of today
  • Currently adjunct devices to laptops, NOT replacements
  • Hard to justify on “cost saving” but easy to justify on WOW factor
  • Be careful of SOPs that are linked into the old way of doing things, may need to be re-written to accommodate the tablet
  • User experience is more important on Ipad than on PCs
    • Users have very low tolerance for clunky Ipad interfaces
    • Some other interesting ideas:
      • KOLs are likely to grab the Ipad so make sure everything you don’t want them to see is locked down
      • Ipad syncing is a manual process and may people may avoid, so build in lock outs to programs to force them to update at least monthly
      • 4 Digit standard Ipad passwords stink – they are breakable in minutes, use a much longer password
      • Use  cloud-based apps like DropBox or Google Drive only after being approved by compliance
      • People want to use their Ipads for personal stuff (photos, music, games) and most companies let them use it for that as well
      • Allow people choice in covers and other accessories since it is very personal
      • Have an accessories swap program to allow people to turn in accessories they no longer want and others can use

-  Odds and Ends Ideas

  • Conduct “Office Hours” during major meetings when top CD resources are available in booth so MSLs can introduce their KOLs
  • Compliance ride alongs – if compliance is unsure of an approach, offer to pilot it with them on a ride along so they can see it in action then make a determination
  • Community MSL group focused on non-HCPs, like Advocacy Group

Obviously, this is merely a few key concepts from the day but it should give you some flavor of the type of discussions and the focus of the meeting.

The meeting remains a very positive experience.  One of the key takeaways from today, however, was the desire of the audience to have more time to interact and learn from each other.  A good problem to have!

Topic 24: Highlights of Day 1 of the Medical and Scientific Communications 2013 Forum

As I mentioned earlier, I am attending the DIA MSC meeting in Pheonix, AZ this week.  The MSC has increased value this year because they have added a track specifically focused on MSLs.  Through the hard work of the MSL Track Chair people Rebecca Vermeulen and Ramineh Zoka, as well as the hard work of all the presenters the MSL Track has had a terrific first day.

DISCLAIMER:  My focus is on interesting information, I did not try to take verbatim notes and will not try to assign comments to a particular speaker.  Any mistakes are mine alone.

In no particular order, some of things are found interesting included:

-  A pill is poison unless the right information is wrapped around it.

-  ACA

  • Because of the passage of the ACA and the Supreme Court upholding the law, Rx spending is expected to increase 4.7% more than is the law had not passed
  • With the ACA’s introduction of roughly 20 million newly insured people in 2014, the US market will become the fastest growing pharmaceutical market in the world

-  Tax Deductibility for Marketing and Sales expenses in Biopharma

  • Some talk about eliminating this to increase tax revenue
  • Proposed 3 times in the last year but killed each time
  • NOT at all clear whether MA would be considered marketing under tax law
  • If passed, likely to see major cuts needed to balance budgets in these areas

-  Sunshine Act

  • Already happening for 16 companies under CIA’s
  • For a taste of the info that will be available, see this link
  • New PhRMA/Coalition formed to educate public about wave of new disclosure information coming called National Dialog for Healthcare Innovation

-  Caronia Ruling (you knew I would have to get something in here about this)

  • No one knows when it will be law of the land but likely 5 to 10 years
  • Old standard of safe – what is on the label
  • New standard will be – information that a reasonable consumer would not find misleading
  • New standard is current FTC standard for all advertisement
  • Data will be king, but not just data submitted to FDA
  • For time being, continue like no change

-  History of MSL Role

  • First MSLs started 40 years ago
  • Up John created role and actually trademarked the name MSL
  • Part of the sales teams – scientific sales

-  MSL Facts of Interest

  • Most MSLs manage between 25 and 49 KOLs
  • 32% of companies surveyed (n~60+) intend to grow MSL team
  • Only 11% intend to shrink MSL teams

-  Value of MSLs by Physicians

  • Surveys showed physicians do NOT value frequency, they value:
    • Accessibility
    • Responsiveness
    • Knowledge
    • Up to date information
    • Do NOT want to meet with MSLs if:
      • Only have old or out of date information
      • Feel they are biased
      • Have nothing new to tell them

-  Diagnostic MSLs

  • Specific MSL group focused on uptake of diagnostics
  • Big challenge – to use a diagnostic, they need the diagnostic platform – often millions of dollars
  • Thus broader array of people involved in decision beyond just HCP, including:
    • Bench Tech
    • Lab Managers
    • Pathologists
    • Administration
    • Opens questions about right regulatory regime for non-HCPs

-  CIA Driven Changes

  • CIAs require standards and documentation
  • Documentation increasingly taking the form of customer relationship management systems specifically for MA
  • Most common system by show of hands in the room: Veeva running on Salesforce.com
  • To be effective, this type of system needs to:
    • Track interactions
    • Manage content
    • Link the two
    • Key pitfalls
      • Privacy, especially for global systems given EU requirements
      • Complexity

Obviously, this is merely a few key concepts from the day but it should give you some flavor of the type of discussions and the focus of the meeting.  Overall I would say the tone was very positive, given the challenges MSLs face in their highly regulated environment.  Everyone at the meeting was confident that MSLs value was high and these challenges could be met.  Look forward to tomorrow.

Caronia Legal Discussion

For those of you who can’t get enough discussion about the Caronia case and its impact on off label promotion, Law Journal TV has done a panel discussion about it.  Worth a watch but mostly confirms what we have been discussing here.

Follow

Get every new post delivered to your Inbox.

Join 36 other followers